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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Stopcock

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  Class 2 Device Recall Infusion Stopcock see related information
Date Initiated by Firm May 10, 2018
Create Date October 20, 2021
Recall Status1 Terminated 3 on September 15, 2023
Recall Number Z-0155-2022
Recall Event ID 88725
510(K)Number K141254  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product medfusion Stopcock, 1-way and 4-way, Model Numbers (REF):
a. 081-101BE
b. 081-101GE
c. 081-101GEE
d. 081-101NE
e. 081-102NE
f. 081-102RE
g. 089-101E
h. 888-101NE
i. 081-102GEE
j. 888-101BE
k. 888-101GE
l. 888-101GEE
m. 081-101RE
n. 081-102GE
o. 081-102BE
p. 888-101RE
Code Information a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402  b. 081-101GE, Serial Numbers: 1570343301  c. 081-101GEE, Serial Numbers: 1470293701, 1570343401  d. 081-101NE, Serial Numbers: 1570323801, 1570341001, 1570342701, 1570344101, 1660688101, 1670354301  e. 081-102NE, Serial Numbers: 1660636701  f. 081-102RE, Serial Numbers: 1660636601  g. 089-101E, Serial Numbers: 1570316801, 1570342601, 1570344601, 1660670001, 1670347801, 1670355201, 1670359701  h. 888-101NE, Serial Numbers: 1570343001  i. 081-102GEE, Serial Numbers: 1660636901  j. 888-101BE, Serial Numbers: 1570319201, 1570343101, 1570344201, 1670348101, 1670348102  k. 888-101GE, Serial Numbers: 1570343201, 1660688201  l. 888-101GEE, Serial Numbers: 1470312301, 1570343501  m. 081-101RE, Serial Numbers: 1570342901  n. 081-102GE, Serial Numbers: 1660637101  o. 081-102BE, Serial Numbers: 1570316901, 1660637501  p. 888-101RE, Serial Numbers: 1570344301, 1670356201 
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 Product has a lack of sterility assurance
FDA Determined
Cause 2		 Package design/selection
Action The firm, Smiths Medical, notified their consignees of the recall by issuing an "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" dated 3/2018 on 05/10/2018. The notice described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: PLEASE TAKE THE FOLLOWING ACTIONS TO HELP US PROPERLY EXECUTE THIS FIELD SAFETY CORRECTIVE ACTION: 1. Identify any affected Infusion Stopcocks in your possession 2. Determine the number of affected products in your possession and complete the Field Safety Notice (FSN) Response Form attached to this letter within 10 days of receipt; return it to smithsmedicalrecall@stericycle.com. The completed Response Form must be returned even if you do not have any of the affected Infusion Stopcocks in your possession. 3. All affected products must be returned to Stericycle for processing. If the completed Response Form indicates that you have product to return. 4. When you receive the pre-paid shipping labels, package the affected products by lot number. Include a copy of the completed Response Form inside EACH BOX of returned products. 5. FOR DISTRIBUTORS ONLY: If you have distributed any of the affected products to your customers, please immediately notify your customers of this Field Safety Corrective Action and retrieve all affected products. If you have any questions regarding this notification, contact Stericycle via email at the following address: smithsmedicalrecall@stericycle.com.
Quantity in Commerce 933,518 units
Distribution International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = ELCAM MEDICAL ACAL
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